Quality Assurance Specialist

Quality Assurance SpecialistPeregrine Team is hiring a Quality Assurance Specialist to support a growing biotech organization focused on developing and manufacturing innovative therapies. This role will play a key part in maintaining quality systems, supporting audits, and ensuring compliance with cGMP standards across manufacturing and operations.Key ResponsibilitiesReview and approve batch records, deviations, and change controls in accordance with cGMP guidelinesSupport internal and external audits, including FDA inspectionsMaintain and update SOPs, quality documentation, and training recordsPartner cross-functionally with manufacturing, regulatory, and quality control teamsAssist with CAPA investigations and root cause analysisQualificationsBachelor's degree in a scientific discipline or related field3–5+ years of experience in a GMP-regulated environment (biotech/pharma preferred)Strong understanding of FDA regulations and quality systemsDetail-oriented with strong documentation and communication skills